India limits cough syrup sales to pharmacies after contamination cases

India has restricted cough syrup sales to licensed pharmacies especially in villages, preventing over-the-counter sales from retail outlets, as regulators step up scrutiny following contamination-linked child deaths last year.

Some cough syrups were previously on an exemption list under drug rules, allowing them to be sold over the counter as household remedies under relaxed regulations.

That allowed vendors with restricted retail licences, often issued in smaller towns or villages without pharmacies and with a population of not more than 1,000, to sell the products. These medicines were often bought without a prescription, including from non-pharmaceutical retail stores.

The government has now removed cough syrups from the exemption list, while allowing pills, tablets and lozenges to remain on it, according to a government notification dated June 15.

“Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act,” a separate statement from the Health Ministry said.

“The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.”

In cities, however, existing rules already require cough syrups to be sold only in registered pharmacies, a health ministry official said on condition of anonymity.

India has come under pressure to tighten oversight of its pharmaceutical industry, which is dominated by small manufacturers and aims to reach a value of $130 billion by 2030.

Since 2022, India-made cough syrups have been linked to the deaths of more than 140 children in Africa and Central Asia, hurting its reputation as the “pharmacy of the world”.

Last October, Sresan Pharmaceutical-made Coldrif syrup was linked to the deaths of 24 children.

The country’s drug regulator said in February it had inspected nearly 90% of cough syrup manufacturers and taken action against non-compliant units.

“We have seen people with chronic cough resorting to self-medication,” said Tushar Tayal, a doctor at Gurgaon’s CK Birla Hospital, adding that the latest move is necessary given the safety and quality concerns.